Global Process Owner, Risk Management

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Global Process Owner, Risk Management

Live

What you will do

Lets do this! Lets change the world!

Amgen is seeking a Senior Manager with responsibility for the Global Risk Management activities at Amgen with a strong emphasis on medical device risk management. This Senior Manager will serve as the Global Process Owner and is responsible for defining, implementing and maintaining risk management activities. These activities ensure that product risk is appropriately assessed, documented and mitigated throughout the entire product life cycle. This manager assures systems and processes remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. Trains and coaches SMEs on how to translate and deploy the architecture to the sites or functional groups, as necessary. Works with key internal partners to enable issues resolution. Drives agile, efficient, effective and sustainable processes, KPIs and linkages between all multiple sources of risk management activities. Interfaces directly with agencies during inspections and provides response to agency requests regarding risk management processes. Works closely with global regulatory and safety to assure Amgens risk management process is adapted to emerging trends or new requirements in regulations.

Key Responsibilities:

• Owns and ensures risk management activities are effectively implemented end to end across the product lifecycle

• Provides guidance to other associates on the application of appropriate risk management practices. Works collaboratively with engineering, design, and product teams to ensure successful translation of requirements into products that are safe and effective for user and enrich the overall user experience across Amgen portfolio or programs.

• Develops procedures which govern all product risk activities. Ensure product risk management procedures and practices incorporate applicable regulations and guidance documents including ICH Q9, ICH Q10, ISO 13485, ISO 14971, 21CFR820, EU MDR IEC 62366, IEC 60601 and IEC 62304

• Establishes appropriate practices for assessing risk during product development activities. Support preparation of the risk management plan. Support preparation of failure mode effect analysis (FMEA) documents to assess potential risks from various sources. Developed FMEAs shall include those for product design (dFMEA), device use (uFMEA) and supplied components (sFMEAs).

• Establishes appropriate practices for assessing risk resulting from manufacturing activities. Support preparation of process failure mode effect analysis (pFMEA) documents.

• Implements practices to update risk management documents throughout the product life cycle. Establish practices for revising FMEAs as appropriate when new information affecting product risk is available. FMEA updates shall include; a) incorporating production quality data into pFMEAs on a continual basis; and b) incorporating customer experience and field data into appropriate risk documents.

• Supports risk management practices and applicable documentation during internal audits and third-party inspections.

• Ensures compliance throughout the network: gap assessments, commitments, response to audit and inspection findings and deviations

• Applies expertise and communicates issues and action plans to management, demonstrating appropriate quality management systems to advance per business process, such as Management Review (MR)

• Drives Operational Excellence and champions change

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Quality experience

OR

Masters degree and 6 years of Quality experience

OR

Bachelors degree and 8 years of Quality experience

OR

Associates degree and 10 years of Quality experience

Or

High school diploma / GED and 12 years of Quality experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• 5+ years of quality engineering experience in medical device, biotech or pharmaceutical industry

• Experience leading medium or large projects at a global level

• Advanced knowledge regulations pertaining to medical devices and combination products

• Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are Agile and phase appropriate

• Cultural awareness and dexterity

• English language fluency- other language skills are an advantage

• Innovation approach with skills for developing ideas into practical objectives

• Leadership skills and the ability to oversee multiple projects simultaneously

• Able to successfully manage workload to timelines

• Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

• Experience driving decision making

• Highly skilled at interacting effectively with inspectors and agency regulators

• Ability to succinctly communicate level of risk, urgency, or impact to the business

• Ability to travel +/- 20% of time to domestic and international Amgen sites

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $143,192 - $170,286.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.